13 January 2025 This Week in Health Policy for January 13 This week, nomination hearings for President-elect Donald Trump’s cabinet nominees are set to get underway, while Republicans will continue to debate plans to act through the budget reconciliation process to extend Tax Cuts & Jobs Act (TCJA) provisions expiring at the end of 2025, act on border issues, and possibly address the federal debt limit. Senate Veterans’ Affairs Committee will hold a hearing on the Nomination of Douglas Collins to be Secretary of Veterans Affairs
Senate Homeland Security and Governmental Affairs will hold a hearing on the Nomination of Russel Vought to be Director, Office of Management and Budget
Senate Finance Committee will hold a hearing to Consider the Anticipated Nomination of Scott Bessent, of South Carolina, to be Secretary of the Treasury
119th Session of Congress begins. On Friday (January 3), the 119th Congress began its session and Mike Johnson (R-LA) was re-elected as House speaker and lawmakers voted to adopt the House rules package, which sets legislative rules for the 119th Congress. This week, lawmakers certified the electoral college votes and continued organization and planning activities for this year. Democrats named new members to key health committees and Republican leadership continued to debate how to use reconciliation to advance President-elect Donald Trump’s legislative agenda, including extending Tax Cuts & Jobs Act (TCJA) provisions expiring at the end of 2025, acting on border issues, and addressing the federal debt limit. Lawmakers also face a March 31 deadline to pass a FY 2025 spending bill or another continuing resolution (CR). In December 2024, Congress passed a short-term CR that extended federal funding to March 31 and included a very narrow package of health extenders, with a three-month extension of Medicare telehealth flexibilities. This means Republicans have three months to address FY 2025 funding, the telehealth flexibilities, and other programs that were allowed to expire, as well as decide whether to address omitted policies such as PBM reform, the drug patent system, MA plan provider directories, physician pay cut offsets, and more. On Thursday (January 9), Rep. Buddy Carter (R-Ga.), chair of the House Energy and Commerce Health subcommittee, told reporters he is talking with leadership to advance the bipartisan health package left out of the final December CR, either in a stand-alone vote or via the reconciliation package. This week, House Energy and Commerce Committee Chair Rep. Brett Guthrie (R-KY) also said he also is eyeing Medicaid reforms, including a potential cap and work requirements, to move as part of the reconciliation package.
CMS issues CY 2026 MA, Part D Advance Notice. On Friday (January 3), the Centers for Medicare and Medicaid Services issued the Calendar Year (CY) 2026 Advance Notice for the Medicare Advantage (MA) and the Medicare Part D Prescription Drug Programs (Advance Notice). The Advance Notice proposes annual, technical updates to MA and Part D and includes plans to complete the agency’s three-year implementation of MA risk adjustment model updates, update the Part D risk adjustment model to align for Inflation Reduction Act changes, update Part C and Part D star ratings, and more. If finalized, CMS estimates the proposed policies and updates would increase payments to MA plans by an average of 4.33%, or over $21 billion, from 2025 to 2026. The Advance Notice will be open for public comment through February 10. CMS intends to publish the final Rate Notice by April 7. Click here for a fact sheet. Click here for the Advance Notice. Click here for a fact sheet. CMS publishes Draft CY 2026 Part D Redesign Program Instructions. On Friday (January 3), CMS released draft instructions to continue to implement the Inflation Reduction Act’s Part D redesign for 2026. The draft instructions contain details and guidance for changes set to take effect January 1, 2026, including the establishment of the select drug subsidy program, which provides Part D sponsors a government subsidy for selected drugs equal to 10% of the drug’s negotiated price, and the updated annual out-of-pocket cap, which will be set at $2,100 for 2026. The draft instructions will be open for public comment through February 10. CMS intends to publish the final program instructions by April 7. Click here for a fact sheet. CMS touts record ACA exchange sign ups. On Wednesday (January 8), CMS announced 23.6 million consumers have selected a health plan through Affordable Care Act exchanges during the 2025 open enrollment period, including 3.2 million new consumers. Open enrollment through the federal exchange is set to close January 15, while state-based marketplace enrollment deadlines vary. Enhanced subsidies that lower premium costs for certain enrollees are set to expire at the end of 2025. VA expands list of cancers covered by PACT Act. On Wednesday (January 8), the Department of Veterans Affairs announced it will add more cancers to the list of those presumed to be related to burn pit exposure and covered by the PACT Act. The additional cancers include bladder cancer, ureter cancer, other genitourinary cancers, acute and chronic leukemias, and multiple myeloma. CMS publishes FAQ on hospital price transparency. On Tuesday (January 7), CMS published an updated frequently asked questions on hospital price transparency compliance requirements, including updates effective January 1, 2025, that were finalized in the Calendar Year 2024 Outpatient Prospective Payment System/Ambulatory Services Center Final Rule. Biden admin finalizes rule blocking medical debt info from credit reports. On Tuesday (January 7), the Consumer Financial Protection Bureau (CFPB) issued a final rule that prohibits lenders from assessing consumers’ medical debt and other medical information, such as medical device usage, when making lending decisions. The rule also bans consumer reporting agencies from including medical debt information on credit reports and credit scores sent to lenders. The rule is set to take effect in March. FDA issues draft guidance on obesity drug development. On Tuesday (January 7), the Food and Drug Administration (FDA) issued draft guidance detailing efficacy standards and other recommendations for drugmakers developing therapies for weight loss and weight management. The draft guidance proposes a minimum of 5% weight-loss compared with a control group after a year of treatment at the maintenance dose to be considered effective for weight loss. The draft guidance will be available for public comment for 90 days. FDA issues draft guidance on AI in drug development and AI-enabled medical devices. On Monday (January 6), the FDA issued separate draft guidance proposing frameworks for AI use in drug and biologic product development and AI-enabled medical devices. The drug and biologic guidance proposes a risk-based framework for sponsors to assess and establish the credibility of an AI model for a particularly use. The medical device guidance provides recommendations to support the development and marketing of AI-enabled devices throughout the total product lifecycle, including recommendations on the design, development, maintain and documentation. Both draft guidance documents will be open for a 90-day comment period. FDA issues draft guidance on post-approval confirmatory trials. On Monday (January 6), the FDA issued draft guidance outlining the agency’s intent to require a confirmatory trial be underway prior to a drug or biologic receiving accelerated approval. The guidance states that, in some cases, the FDA may require enrollment to be complete at the time of approval and provides details on factors FDA will consider when making those determinations. The agency also notes that in limited circumstances the confirmatory trial requirement may not be needed or feasible, noting the unique challenges that sponsors seeking approval for rare disease drugs intended may encounter in initiating post-approval confirmatory trials prior to approval. FDA said it would address in other guidance statutory authorities to help ensure timely study completion, including conditions for the progress of a post-approval trial. The draft guidance will be available for public comment for 60 days. FDA issues draft guidance on tissue biopsies in clinical trials. On Monday (January 6), the FDA issued the FDA issued draft guidance detailing when a tissue biopsy should be included in a clinical trial protocol, including risk and benefit considerations for trials involving children. The draft guidance will be available for public comment for 60 days. CMS announces Transforming Maternal Health model participants. On Monday (January 6), CMS announced the 15 states participating in the Transforming Maternal Health (TMaH) model. The model, which launched on January 1, supports participating state Medicaid agencies in developing a whole-person approach to pregnancy, childbirth, and postpartum care. HHS publishes proposed rule updating HIPAA cybersecurity standards. On Monday (January 6), the Department of Health and Human Services Office for Civil Rights published a notice of proposed rulemaking to update cybersecurity standards related to electronic protected health information (ePHI). The rule, if finalized, would mark the first update to the so-called Security Rule since 2013, and aims to account for recent changes in the health care environment and the growing number of cyberattacks targeting health care entities. The rule is open for comment until March 7. Click here for a fact sheet. Surgeon General warns about link between alcohol and cancer risk. On January 3, US Surgeon General Dr. Vivek Murthy released a new advisory to increase awareness on the links between alcohol consumption and increased cancer risk. SAMHSA awards new grants to support maternal behavioral health. On December 31, the Substance Abuse and Mental Health Services Administration (SAMHSA) awarded $10 million in grants to support community-based maternal behavioral health services. DOJ finalizes rule on US sensitive data sharing with countries of concern. On December 27, the Department of Justice (DOJ) issued a final rule that prohibits or restricts transactions involving bulk sensitive personal data – including personal health data, human genomic data, and biometric identifiers — between US companies and individuals or entities located in DOJ-designated countries of concern. The rule was largely finalized as proposed, but DOJ made some technical updates and clarifications. For example, DOJ provided some more clarity around the exemptions for drugs and biologics. Most provisions in the rule are scheduled to take effect April 8, though DOJ delayed until October 6, the effective date for US persons to comply with due diligence and audit requirements for restricted transactions. The rule’ reporting requirements are also scheduled to take effect October 6. Click here for a fact sheet. DeGette and Bucshon issue next steps on 21st Century Cures initiative. On December 24, Rep. Diana DeGette (D-CO) and former Rep. Larry Bucshon, MD (R-IN) published a white paper outlining next steps and policy proposals for a potential “Cures 2.1” legislation. The issue paper includes policies to ensure that advances in technology and products are available to patients who need them, including modernizing Medicare coverage and payment mechanisms to provide access to high-cost treatments, such as gene therapies. The discussion draft also calls for modernizing remote patient monitoring policies and permanently expanding telehealth and hospital-at-home Medicare flexibilities. Biden admin withdraws proposed rule on contraceptive coverage. On December 23, The Departments of Health and Human Services, Treasury, and Labor withdrew a February 2023 proposed rule that would have expanded access to contraceptive services under the Affordable Care Act by eliminating the exemption for objections based on nonreligious grounds and creating a new process to provide coverage for individuals covered by plans subject to a religious exemption. The department cited limited time and resources as a contributing factor to the withdrawal. CMS publishes list of Part B inflation rebate drugs. On December 20, CMS published the latest list of Part B drugs that will be subject to the Inflation Reduction Act’s Medicare Prescription Drug Inflation Rebate Program. The list includes 64 drugs that will have lower Part B coinsurance from the first quarter of 2025 because prices rose faster than the rate of inflation. CMS noted that since the program launched April 1, 2023, more than 120 drugs have been subject to the program. President Biden signs several health bills into law. On December 23, President Biden signed into law several health bills including the HEARTS Act of 2024 (HR 6829), the Emergency Medical Services for Children Reauthorization Act of 2024 (HR 6960), and the Autism CARES Act of 2024 (HR 7213). The HEARTS Act mandates the HHS Secretary launch a private-public sector initiative to develop and distribute educational materials on cardiomyopathy, while the other bills reauthorize programs for certain emergency medical services and several HHS autism programs. Senate Budget Committee releases bipartisan staff report on private equity involvement in health care. The report, spearheaded by Sens. Sheldon Whitehouse (D-RI) and Chuck Grassley (R-Iowa), who served as chair and ranking member of the committee in the 118th Congress (for the 119th Congress the committee leaders have swapped roles), accuses private equity firms of prioritizing profits over patient care. The report does not make any specific policy recommendations but raises concerns about private equity’s role in health care.
House Select Committee on the Chinese Communist Party sent letter to Commerce Secretary on clinical trials at Chinese military hospitals. On Thursday (January 9), Select Committee Chairman John Moolenaar (R-MI), Ranking Member Raja Krishnamoorthi (D-IL), and Rep. Neal Dunn (R-FL) sent a letter to Secretary of Commerce Gina Raimondo, calling on the Department to update its regulations to require drugmakers to obtain licensing before entering an agreement to conduct clinical trials at Chinese military hospitals.
HHS: HHS Artificial Intelligence Strategic Plan. The report details four strategic goals HHS intends to deploy across various domains, including leveraging health AI innovation to improve people’s lives, promoting trustworthy AI development and ethical and responsible use, democratizing AI to promote access, and cultivating AI-empowered workforce and organization cultures to effectively and safely use AI. US Trade Representative: 2024 Review of Notorious Markets for Counterfeiting and Piracy. The annual report examines the growth in illicit online pharmacies and counterfeit medicines, identifying 38 online markets and 33 physical markets, many based in China, that may engage in or facilitate trademark counterfeiting or copyright piracy and calls on US trading partners to improve enforcement actions. Congressional Research Service: Artificial Intelligence (AI) in Health Care. The report provides an overview of federal health agency activity on AI and recommendations on areas where Congress may seek to harmonize regulatory requirements. CMS: Report to Congress: Fiscal Year 2023 The Centers for Medicare & Medicaid Services’ COVID-19 Public Health Emergency Response and Use of Section 1135 Waivers and other Flexibilities. The report highlights CMS’ policy response to the FY 2023 COVID-19 public health emergency covering six key areas: vaccines and therapeutics, testing, telehealth, emergency reporting, surge capacity, and long-term care facilities.
Document ID: 2025-0214 | |||||
